August 16, 2010 - IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections
must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.

September 29, 2010 (NOT-OD-11-007) - NIH to Require Use of Updated Electronic Application Forms in 2011. Adobe B1 forms are required for due dates on or after May 8, 2011.

Program
Announcement (PA) Number: PAR-10-267

Notice: Applications submitted in response to the Funding
Opportunity Announcement (FOA) for Federal assistance must be submitted
electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424
(R&R) Application Guide.

APPLICATIONS
MAY NOT BE SUBMITTED IN PAPER FORMAT.

This
FOA must be read in conjunction with the application guidelines included with
this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A
registration process is necessary before submission and applicants are highly
encouraged to start the process at least four (4) weeks prior to the grant
submission date. See Section
IV.

A
compatible version of Adobe Reader is required for download. For assistance
downloading this or any Grants.gov application package, please contact
Grants.gov Customer Support at http://grants.gov/CustomerSupport.

Catalog of Federal Domestic Assistance Number(s)93.242

Key Dates
Release/Posted Date: August 20, 2010
Opening Date: September 20, 2010 (Earliest date an application may be
submitted to Grants.gov)Letters of Intent Receipt
Date(s): 30 days before the submission dateNOTE: On-time submission requires that applications be successfully
submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant
institution/organization).Application Submission/Receipt Date(s):October 19, 2010, then September 25
annuallyfor new, resubmission, renewal, and revision applicationsPeer Review Date(s):February/March annuallyCouncil Review Date(s):May annuallyEarliest Anticipated Start Date(s):July 1 annuallyAdditional Information To Be
Available Date (Activation Date):Not ApplicableExpiration/Closing Date: (Now Expired August 10, 2012 per issuance of PAR-12-262), Originally September 26, 2012

Due Dates for E.O. 12372Not Applicable

Additional Overview Content

Executive Summary

Purpose: This funding opportunity
announcement (FOA) issued by the National Institute of Mental Health (NIMH)
encourages Research Education Grant (R25) applications from
Institutions/Organizations that propose creative and innovative research
educational programs to facilitate the development of a cadre of investigators
in appropriate scientific areas to fulfill the objectives
of the NIMH Strategic Plan (http://www.nimh.nih.gov/about/strategic-planning-reports/index.shtml). The
interests of the NIMH are broad, spanning from basic neuroscience, human genetics/genomics
and translational research to interventions and mental health services research
across the lifespan. While not limited to the categories and
examples provided below, the NIMH is particularly interested in innovative R25
applications that propose to develop short courses or workshops, research
mentoring networks, activities during medical school and/or residency that
encourage the development of research-oriented physician-scientists, or that
combine didactic instruction with ongoing mentoring and research opportunities.

Mechanism
of Support: This FOA will
use the NIH Research Education (R25) award
mechanism. Research education programs may not
be transferred from one institution to another, unless strongly justified (see
Section VI.2).

Funds Available and Anticipated
Number of Awards. Because the nature and scope of the
proposed research education program will vary from application to application,
it is anticipated that the size and duration of each award will also vary. The
total amount awarded and the number of awards will depend upon the mechanism,
numbers, quality, duration, and costs of the applications received.

Budget and Project Period: The total project period for an application submitted in
response to this FOA may not exceed five years. The direct costs are limited to
$250,000 annually. All personnel costs (including administrative and clerical
costs, as well as salaries of the PD/PI and other investigators/faculty)
associated with directing, coordinating, administering, and implementing the
program should be justified and reasonable. Personnel costs cannot exceed 25%
of the requested directs costs annually.

Application
Research Strategy Length: The R25 application Research Education Program Plan (uploaded via the Research Strategy section) of the PHS398 Research Plan
Component (SF424 Application Guide, Section 5.5) may not exceed 25 pages,
including tables, graphs, figures, diagrams, and charts.

Eligible Project Directors/Principal Investigators
(PDs/PIs): Individuals with the skills, knowledge, and resources
necessary to carry out the proposed research education program are invited to
work with their institution/ organization to develop an application for
support. Individuals from underrepresented racial and ethnic groups as well as
individuals with disabilities are always encouraged to apply for NIH support.

Number
of PDs/PIs: More than one PD/PI (i.e., multiple PDs/PIs) may be designated on the
application.

Number
of Applications: Applicants may submit more than one application,
provided each application is scientifically distinct.

Resubmissions: Applicants may
submit a resubmission application, but such
application must include an Introduction addressing the previous peer
review critique (Summary Statement). See new NIH policy on resubmission
(amended) applications (NOT-OD-09-003, NOT-OD-09-016).

Renewals: Renewal applications are allowed for this research
education program.

The NIMH expects applicant
institutions to propose their own creative and innovative research education programs. While
not limited to the categories and examples provided below, the NIMH is
particularly interested in R25 applications that propose to fulfill one or more
objectives of the NIMH Strategic Plan via:

State-of-the-art short courses or workshops.

Research mentoring networks.

Innovative activities during medical school and/or
residency that encourage the development of research-oriented
physician-scientists.

Novel research education programs that combine didactics
with ongoing mentoring and research opportunities.

NIMH R25 grants support
the development and implementation of educational activities targeting
individuals at the career stage of graduate/medical students, medical
residents, and/or postdoctoral scholars. It is allowable for individuals who
are beyond the postdoctoral stage to participate in short-courses and
workshops; however, part-time research training experiences across an academic
year are not allowed for individuals who are beyond postdoctoral training.

Although research education
grants are not typical research instruments, they do involve experiments in
education and/or dissemination of research knowledge that require an evaluation
plan in order to determine their effectiveness. Therefore,all
proposed research educational programs must include evaluation plans that
identify specific and measurable research education
objectives or milestones.

The proposed research
education program may complement other, ongoing research training and education
occurring at the applicant institution, but the proposed educational
experiences must be distinct from those research training and research
education programs currently receiving federal support. The R25 is not a
substitute for an institutional research-training program (T32), and cannot be
used to circumvent or supplement Ruth L. Kirschstein National Research Service
Award (NRSA) programs. An R25 program cannot be used to support the research of
participants conducting 12-month, full-time biomedical research.

NIMH anticipates the
publication of a separate FOA to support research education in the area of
HIV/AIDS, issued by the Division of AIDS Research.

This FOA will use the NIH Research Education Grant
(R25) award mechanism. The Project Director/Principal Investigator (PD/PI) (or
multiple PD(s)/PI(s) if multiple PD/PI option is used) will be solely
responsible for planning, directing, and executing the proposed research
education program.

This
FOA uses just-in-time concepts (see SF424 (R&R) Application Guide). It also uses the
non-modular budget format. Applicants must complete and submit budget requests
using the SF424 Research and Related (R&R) Budget Component found in the
application package for this FOA.

Research education grant support is renewable.
It is recommended that applicants contact the scientific/research contact
listed in Section VII concerning the submission of a renewal (formerly
“competing continuation”) application. Only one resubmission (formerly
“revisions/amendments”) of a previously reviewed
research education grant application may be submitted. See NOT-OD-09-003 and NOT-OD-09-016.

2.
Funds Available

Because the nature and scope of the proposed research
education program will vary from application to application, it is anticipated
that the size and duration of each award will also vary. Although the financial
plans of theNIMHprovide support for this
program, awards pursuant to this funding opportunity are contingent upon the
availability of funds and the submission of a sufficient number of meritorious
applications.

The total project
period for an application submitted in response to
this funding opportunity may not exceed 5 years. Although the size of the award may vary with the scope of the research education program proposed,
applications must stay within the following budgetary guidelines: total direct costs are limited to $250,000annually, and personnel costs may not exceed 25% of the
direct costs in any year of the project period.

Facilities and Administrative (F&A) costs
requested by consortium participants are not included in the direct cost
limitation. See NOT-OD-05-004.

Allowable Costs: Allowable costs must
be consistent with NIH policy and be reasonable, allocable, well documented and
fully justified for the research education program proposed in the application.
Grant funds may not be used to supplant funds otherwise available at the
applicant institution, nor can they be used to circumvent or supplement funds
provided to individuals supported by Ruth L. Kirschstein National Research
Service Award (NRSA) programs.

Personnel: These requested expenses must be itemized in Sections A and B, as appropriate,
of the Research & Related Budget. Individuals (PD/PIs) designing,
directing, and implementing the research education program may request salary
and fringe benefits appropriate for the person months devoted to the program.
Salaries requested may not exceed the levels commensurate with the
institution's policy for similar positions and may not exceed the congressionally
mandated cap. (If mentoring interactions and other activities with
students/participants are considered a regular part of an individual's academic
duties, then any costs associated with the mentoring and other interactions
with students/participants are not allowable costs from grant funds.) Personnel costs (including administrative and
clerical costs) associated with directing, coordinating, administering, and
implementing the program may not exceed 25% of the direct costs in any year of
the project period.

Other Program-Related
Expenses: These expenses must be itemized, as appropriate, in Sections C. (Equipment), D.
(Travel), and F. (Other Direct Costs) of the Research & Related Budget.
Consultant costs, equipment, supplies, travel for key persons, and other
program-related expenses must be justified as specifically required by the
proposed research education program and must not duplicate items generally
available for educational programs at the applicant institution.

Participant Costs: Participants are
those individuals who benefit from the proposed research education program. In
some instances, participants may be paid if specifically required for the
proposed research education program and sufficiently justified. Participant
costs must be itemized in Section E. (Participant/Trainee Support Costs) of the
Research & Related Budget.

Allowable participant
costs depend on the educational level/career status of the individuals selected
to participate in the program. Graduate students, including health professional
students, may receive compensation in accordance with the NIH policy for
graduate student compensation (see: NOT-OD-02-017). Amounts for all
participants must conform to the established, consistently applied salary and
wage policies of the institution and reflect the percentage of time/effort
devoted to the program. In addition to salary (or subsistence allowance) and
fringe benefits, participants may receive costs of meals and lodging unless
such costs are furnished as part of the registration fee. Participants may also
receive funds to defray partial tuition, other education-related, and travel
expenses. Expenses for foreign travel must be exceptionally well justified.

Participants
involved in part-time research training activities may receive limited funds
for research supplies associated with the project, including statistical
support, but may not receive funds from the R25 program to support pilot research
studies.

Because this is an educational
and not a training mechanism, non-U.S. citizens may participate
in this program. However, requests for participation of non-U.S. citizens under
the auspices of this FOA should be made with the understanding that this mechanism is not to be used to circumvent or
supplement NRSA training mechanisms. Unless strongly justified on the basis of
exceptional relevance to the NIH/IC mission, research education programs should
be used primarily for the education of U.S. citizens. Applicants are
strongly encouraged to contact Program staff (see Section VII) to discuss the appropriate
utilization of this mechanism with respect to the eligibility, appointment, and
participation of non-U.S. citizens.

Individuals supported by NIH
training and career development mechanisms (K, T, or F awards) may receive, and
indeed are encouraged to receive, educational experiences supported by the R25
mechanism, as participants, but may not receive salary or stipend supplementation from a research education program.

Because the R25
mechanism is not intended as a substitute for an NRSA institutional training
program (T32), costs to support full-time participants are not allowable. A
full-time participant is defined for the research
education program as an individual supported for 40 hours/week for a
continuous, 12-month period or as specified by the
sponsoring institution in accordance with its own policies.

Facilities and
Administrative (F&A) Costs: F&A costs for the applicant organization
and consortium participants will be reimbursed at 8 percent of modified total
direct costs (exclusive of tuition, fees, and equipment).

NIH grants policies as described in the NIH Grants Policy Statement will apply to the
applications submitted and awards made in response to this FOA.

Foreign institutions are not
eligible to apply in response to this FOA.

In many cases, it is anticipated that the proposed research
education program will complement ongoing research training occurring at the
applicant institution and that a substantial number of program faculty will
have active research projects in which participants may gain relevant
experiences consistent with their research interests and goals. Institutions
with existing Ruth L. Kirschstein National Research Service Award (NRSA)
institutional training grants (e.g., T32) or other federally funded training
programs may apply for a research education grant provided that the proposed
educational experiences are distinct from those training programs receiving NIH
support. Moreover, the R25 mechanism is not intended to support long-term
training by NRSA-eligible individuals and may not be used to circumvent or
supplement Ruth L. Kirschstein NRSA research training mechanisms.

If multiple sites are involved in the research education
program, the applicant institution must be one of these sites for the program.
The need for and use of multiple sites must be justified.

1.B. Eligible Individuals

Any individual(s) with the skills, knowledge, and
resources necessary to carry out the proposed research education program as the
PD/PI is invited to work with his/her organization to develop an application
for support. Individuals from underrepresented racial and ethnic groups as well
as individuals with disabilities are always encouraged to apply for NIH
support.

The PD/PI should be an established investigator in the
scientific area in which the application is targeted and capable of providing
both administrative and scientific leadership to the development and
implementation of the proposed research education program.

The PD/PI will be expected to monitor and assess the
program and submit all documents and reports as required (See Section VI.3.
“Reporting.”)

More than one PD/PI (i.e.,
multiple PDs/PIs) may be designated on the application for projects that
require a “team science” approach and therefore clearly do not fit the
single-PD/PI model. Additional information on the implementation
plans and policies and procedures to formally allow more than one PD/PI on
individual research projects is available at http://grants.nih.gov/grants/multi_pi.All PDs/PIs must be
registered in the NIH electronic Research Administration (eRA) Commons prior to the submission of
the application (seehttp://grants.nih.gov/grants/ElectronicReceipt/preparing.htmfor instructions).

The decision of whether to apply for a grant with a
single PD/PI or multiple PDs/PIs grant is the responsibility of the
investigators and applicant organizations and should be determined by the
scientific goals of the project. Applications for grants with multiple PDs/PIs
will require additional information, as outlined in the instructions below.
When considering the multiple PD/PI option, please be aware that the structure
and governance of the PD/PI leadership team as well as the knowledge, skills
and experience of the individual PDs/PIs will be factored into the assessment
of the overall scientific merit of the application. Multiple PDs/PIs on a
project share the authority and responsibility for leading and directing the
research education program, intellectually and logistically. Each PD/PI is
responsible and accountable to the grantee organization, or, as appropriate, to
a collaborating organization, for the proper conduct of the project or program,
including the submission of required reports. For further information on
multiple PDs/PIs, please seehttp://grants.nih.gov/grants/multi_pi.

Sponsoring Institution: The sponsoring
institution must assure support for the proposed research education program.
Appropriate institutional commitment to the program includes the provision of
adequate staff, facilities, and educational resources that can contribute to
the planned research education program. The application must have a strong
research program in the area(s) proposed for research education and should
include a letter explaining the institutional commitment to the proposed
research education program.

Participants:NIMH
R25 grants support the development and implementation of educational activities
targeting individuals at the career stage of graduate/medical students, medical
residents, and/or postdoctoral scholars. It is allowable for individuals who
are beyond the postdoctoral stage to participate in short courses and
workshops; however, support for part-time research training experiences across
an academic year is not allowed for individuals who are beyond postdoctoral
training. While non-U.S. citizens may participate in research education programs, research education
programs should be used primarily for the education of U.S. citizens.

Number of Applications: Applicants may submit more
than one application, provided each application is scientifically distinct.

Resubmissions: Applicants may submit a
resubmission application, but such application must include an Introduction
addressing the previous peer review critique (Summary
Statement). See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016.

Renewals: Renewal applications are allowed for this
research education program.

Appropriate registrations with Grants.gov and
eRA Commons must be completed on or before the due date in order to
successfully submit an application. Several of the steps of the registration
process could take four weeks or more. Therefore, applicants should immediately
check with their business official to determine whether their
organization/institution is already registered with both Grants.gov and the Commons. All registrations
must be complete by the submission deadline for the application to be
considered “on-time” (see Section IV.3.C.1 for more information
about on-time submission).

A one-time registration is required for
institutions/organizations at both:

The individual(s) designated as PDs/PIs
on the application must be registered also in the NIH eRA Commons. In
the case of multiple PDs/PIs, all PDs/PIs must be registered and be
assigned the PI role in the eRA Commons prior to the submission of the
application.

Each PD/PI must hold a PD/PI account in
the Commons. Applicants should not share a Commons account for both an
Authorized Organization Representative/Signing Official (AOR/SO) role and
a PD/PI role; however, if they have both a PD/PI role and an Internet
Assisted Review (IAR) role, both roles should exist under one Commons
account.

When multiple PDs/PIs are proposed, all
PDs/PIs at the applicant organization must be affiliated with that
organization. PDs/PIs located at another institution need not be
affiliated with the applicant organization, but must be affiliated with
their own organization to be able to access the Commons.

This registration/affiliation must be
done by the AOR/SO or his/her designee who is already registered in the Commons.

Both the PDs/PI(s) and AOR/SO need separate
accounts in the NIH eRA Commons since both are authorized to view the
application image.

Note: The registration process is not sequential.
Applicants should begin the registration processes for both Grants.gov and eRA
Commons as soon as their organization has obtained a DUNS number. Only one DUNS
number is required and the same DUNS number must be referenced when completing
Grants.gov registration, eRA Commons registration and the SF424 (R&R) forms.

1. Request Application Information

Applicants must download the SF424 (R&R)
application forms and the SF424 (R&R) Application Guide for this FOA
through Grants.gov/Apply.

Note: Only the forms package directly attached to a
specific FOA can be used. You will not be able to use any other SF424 (R&R)
forms (e.g., sample forms, forms from another FOA), although some of the
"Attachment" files may be useable for more than one FOA.

The
SF424 (R&R) Application Guide is critical to submitting a complete and
accurate application to NIH. Some fields within the SF424 (R&R) application
components, although not marked as mandatory, are required by NIH (e.g., the
“Credential” log-in field of the “Research & Related Senior/Key Person
Profile” component must contain the PD/PI’s assigned eRA Commons User ID).
Agency-specific instructions for such fields are clearly identified in the
Application Guide. For additional information, see “Frequently Asked Questions
– Application Guide, Electronic Submission of Grant Applications.”

The SF424 (R&R) application has several
components. Some components are required, others are optional. The forms
package associated with this FOA in Grants.gov/APPLYincludes all
applicable components, required and optional. A completed application in
response to this FOA includes the data in the following components:

Applications with Multiple
PDs/PIs: When
multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the
"Contact” PI, who will be responsible for all communication between the
PDs/PIs and the NIH, for assembling the application materials outlined below,
and for coordinating progress reports for the project. The contact PD/PI must
meet all eligibility requirements for PD/PI status in the same way as other
PDs/PIs, but has no other special roles or responsibilities within the project
team beyond those mentioned above.

Information for the Contact PD/PI should be entered on
the SF424(R&R) Cover component. All other PDs/PIs should be listed in
the Research & Related Senior/Key Person component and assigned the project
role of “PD/PI.” Please remember that all PDs/PIs must be registered in
the eRA Commons prior to application submission. The Commons ID of each
PD/PI must be included in the “Credential” field of the Research & Related
Senior/Key Person component. Failure to include this data field will cause
the application to be rejected.

All
projects proposing Multiple PDs/PIs will be required to include a new section
describing the leadership of the project.

Multiple PD/PI Leadership Plan: For applications designating
multiple PDs/PIs, the section of the Research Plan, entitled “Multiple PD/PI
Leadership Plan”, must be included. A rationale for choosing a multiple PD/PI
approach should be described. The governance and organizational structure of
the leadership team and the Research Plan should be described, and should
include communication plans, process for making decisions on scientific
direction, and procedures for resolving conflicts. The roles and
administrative, technical, and scientific responsibilities for the project or
program should be delineated for the PDs/PIs and other collaborators.

If budget allocation is planned, the distribution of
resources to specific components of the program or the individual PDs/PIs
should be delineated in the Leadership Plan. In the event of an award, the
requested allocations may be reflected in a footnote on the Notice of Award.

Applications Involving a Single Institution: When all PDs/PIs are within a
single institution, follow the instructions contained in the SF424 (R&R)
Application Guide.

Applications Involving Multiple Institutions:If multiple sites are involved in the
research education program, the applicant institution must be one of these
sites for the program. The need for and use of multiple sites must be
justified.

Funding for the other institutions(s) must be
requested via a subcontract to be administered by the primary institution. When
submitting a detailed budget, the primary institution should submit its budget
using the Research & Related Budget component. All other institutions
should have their individual budgets attached separately to the Research &
Related Subaward Budget Attachment(s) Form. See Section 4.8 of the SF424
(R&R) Application Guide for further instruction regarding the use of the
subaward budget.

Prospective applicants are asked to submit a letter of
intent that includes the following information:

Descriptive
title of proposed research education program.

Name, address,
and telephone number of the PD(s)/PI(s).

Names of other
key personnel.

Participating
institutions.

Number and title
of this funding opportunity.

Although a letter of intent is not required, is not
binding, and does not enter into the review of a subsequent application, the
information that it contains allows IC staff to estimate the potential review
workload and plan the review.

To submit an application in response to this FOA, applicants should access this
FOA via http://www.grants.gov/Apply and follow steps 1-4. Note: Applications must only be submitted electronically.
PAPER APPLICATIONS WILL NOT BE ACCEPTED. All attachments must be provided
to NIH in PDF format, filenames must be included with no spaces or special
characters, and a .pdf extension must be used.

In order to expedite the review, applicants are
requested to notify the NIMH Referral Office by email (NIMHReferral@mail.nih.gov) when the application has
been submitted. Please include the FOA number and title, PD/PI name, and title
of the application.

Applications may be submitted on or after the
opening date and must be successfully received by Grants.gov no later
than 5:00 p.m. local time (of the
applicant institution/organization) on the application due date(s). (See Section
IV.3.A. for all dates.) If
an application is not submitted by the due date(s) and time, the application
may be delayed in the review process or not reviewed. All applications must
meet the following criteria to be considered “on-time”:

All
registrations must be complete prior to the submission deadline

The
application must receive a Grants.gov tracking number and timestamp (or eRA
help desk ticket confirming a system issue preventing submission) by 5:00 p.m.
local time on the submission deadline date.

Any
system identified errors/warnings must be corrected and the submission process
completed within the “error correction window.”

Submission to Grants.gov
is not the last step – applicants must follow their application through to the
eRA Commons to check for errors and warnings and view their assembled
application!

3.C.2 Two Day Window to Correct eRA
Identified Errors/Warnings

IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond.
As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See
NOT-OD-10-123.

Once an application package has been successfully
submitted through Grants.gov, NIH provides applicants a two day error
correction window to correct any eRA identified errors or warnings before a
final assembled application is created in the eRA Commons. The standard error
correction window is two (2) business days, beginning the day after the
submission deadline and excluding weekends and standard federal holidays. All
errors must be corrected to successfully complete the submission process.
Warnings will not prevent the application from completing the submission
process.

Please note that the following
caveats apply:

Initial
application submission must be “on-time.”

The
AOR/institutions is expected to enforce that application changes made within
the error correction window are restricted to those necessary to address
system-identified errors/warnings. NIH may reject any application that
includes additional changes.

Proof of “on-time” submission (e.g., Grants.gov timestamp and
tracking number) and description of all changes made within the window must be
documented in the PHS 398 Cover Letter component of the application.

3.C.3 Viewing an
Application in the eRA Commons

Once any eRA
identified errors have been addressed and the assembled application
has been created in the eRA Commons, the PD/PI and the Authorized Organization
Representative/Signing Official (AOR/SO) have two weekdays (Monday – Friday,
excluding Federal holidays) to view the assembled application before it automatically moves forward to NIH for further
processing.

If everything is
acceptable, no further action is necessary. The application will
automatically move forward to the Division of Receipt and Referral in the
Center for Scientific Review for processing after two weekdays, excluding Federal holidays.

Prior to the submission deadline, the
AOR/SO can “Reject” the assembled application and submit a
changed/corrected application within the two-day viewing window. This
option should be used if it is determined that some part of the
application was lost or did not transfer correctly during the submission
process, the AOR/SO will have the option to “Reject” the application and
submit a Changed/Corrected application. In
these cases, please contact the eRA Help Desk to ensure that the issues
are addressed and corrected. Once rejected, applicants should follow the
instructions for correcting errors in Section 2.12 of the SF 424 (R&R)
application guide, including the requirement for cover letters on late
applications. The
“Reject” feature should also be used if you determine that warnings are
applicable to your application and need to be addressed now. Remember, warnings do not stop further application
processing. If an application submission results in warnings (but no
errors), it will automatically move forward after two weekdays if no action is taken. Some warnings may need to be addressed later in the process.

If
the two-day window falls after the submission deadline, the AOR/SO will have
the option to “Reject” the application if, due to an eRA Commons or
Grants.gov system issue, the application does not correctly reflect the
submitted application package (e.g., some part of the application was lost or
didn’t transfer correctly during the submission process). The AOR/SO should
first contact the eRA Commons Helpdesk to confirm the system error,
document the issue, and determine the best course of action. NIH will not
penalize the applicant for an eRA Commons or Grants.gov system issue.

If
the AOR/SO chooses to “Reject” the image after the submission deadline for a
reason other than an eRA Commons or Grants.gov system failure, a
changed/corrected application still can be submitted, but it will be subject to
the NIH late policy guidelines and may not be
accepted. The reason for this delay should be explained in the cover letter
attachment.

Both
the AOR/SO and PD/PI will receive e-mail notifications when the application is
rejected or the application automatically moves forward in the process after
two weekdays.

Upon receipt, applications will be evaluated for
completeness by the CSR. Incomplete applications will not be reviewed.

There will be an acknowledgement of receipt of
applications from Grants.gov and the Commons. The submitting AOR/SO receives the Grants.gov
acknowledgments. The AOR/SO and the PI receive Commons acknowledgments.
Information related to the assignment of an application to a Scientific Review
Group is also in the Commons.

Note:
Since email can be unreliable, it is the responsibility of the applicant to
check periodically on the application status in the Commons.

The NIH will not accept any application in response to
this FOA that is essentially the same as one currently pending initial merit
review unless the applicant withdraws the pending application. The NIH will not
accept any application that is essentially the same as one already reviewed.
However, the NIH will accept a resubmission application, but such application
must include an Introduction (limited to 3 pages) addressing the critique from
the previous review.

All NIH awards are subject to the terms and
conditions, cost principles, and other considerations described in the NIH
Grants Policy Statement.

Pre-award costs are allowable. A grantee may, at its
own risk and without NIH prior approval, incur obligations and expenditures to
cover costs up to 90 days before the beginning date of the initial budget
period of a new or renewal award if
such costs: 1) are necessary to conduct the project, and 2) would be allowable
under the grant, if awarded, without NIH prior approval. If specific
expenditures would otherwise require prior approval, the grantee must obtain
NIH approval before incurring the cost. NIH prior approval is required for any
costs to be incurred more than 90 days before the beginning date of the initial
budget period of a newor renewal award.

The incurrence of pre-award costs in anticipation of a
competing or non-competing award imposes no obligation on NIH either to make
the award or to increase the amount of the approved budget if an award is made
for less than the amount anticipated and is inadequate to cover the pre-award
costs incurred. NIH expects the grantee to be fully aware that pre-award costs
result in borrowing against future support and that such borrowing must not
impair the grantee's ability to accomplish the project objectives in the
approved time frame or in any way adversely affect the conduct of the project. See theNIH Grants Policy
Statement.

The applicant organization must include its DUNS
number in its Organization Profile in the eRA Commons. This DUNS number must
match the DUNS number provided at CCR registration with Grants.gov. For additional
information, see “Frequently Asked Questions – Application Guide, Electronic Submission
of Grant Applications.”

PHS 398 Research Plan Component
Sections

Page limitations must be followed as outlined in the
SF424 (R&R) Application Guide.

The Introduction for a
resubmission application is limited to three pages.

The Introduction for a
revision application is limited to one page.

Specific Aims (Item 2)
is limited to 1 page.

The Research Education
Program Plan must be uploaded using the Research Strategy section (Item 3
of the Research Plan). This section may not exceed 25 pages, including
tables, graphs, figures, diagrams, and charts.

Research
Education Program Plan (Item 3): The Research Education Program Plan must be uploaded
using the Research Strategy section, and must include the following components:

Proposed
Research Education Program (Component of Item 3): While the proposed research education program may
complement ongoing research training and education occurring at the applicant
institution, the proposed educational experiences must be distinct from those
research training and research education programs currently receiving federal
support. When research training programs are on-going in the same department,
the applicant organization should clearly describe the distinction between the
intended participants in the proposed research education program and the
research training supported by the training program. The information should include
a description of the education and/or career levels of the planned
participants. The application should provide programmatic detail on the
specific activities proposed (e.g., courses, curricula, seminars, workshops). The
application should also describe expected processes for: (a) planning and
implementing the proposed educational activities, (b) selecting mentors for
participants (where appropriate), and (c) coordinating among existing training
or research activities available at the site (where appropriate). Organizations
participating in joint applications should demonstrably be involved in the
planning, implementation, and assessment of the program. If an advisory
committee is proposed, describe the function, structure, and composition of
this committee and the frequency of meetings.

Institutional Environment and Commitment (Component of Item
3): Describe the institutional environment, including facilities
and educational resources, that can contribute to the planned Research
Education Program. Evidence of
institutional commitment to the research educational program is required. A letter of institutional commitment must be
attached at line item 14 (Letters of Support). Appropriate institutional
commitment may include the provision of adequate staff, facilities, and
educational resources that can contribute to the planned research education
program.

Program
Director/Principal Investigator (Component of Item 3): For multiple PD/PI Leadership Plan, see instructions for the Multiple PD/PI Leadership
Plan section of the Research Plan. Describe arrangements for
administration of the program, provide evidence that the Program Director is
actively engaged in research and/or teaching in an area related to the mission
of the NIMH, and can organize, administer,
monitor, and evaluate the research education program, as well as evidence of
institutional and community commitment and support for the proposed program.

Program
Faculty/Staff (Component of Item 3): Describe the characteristics
and responsibilities of the participating faculty; provide evidence that the
participating faculty and preceptors are actively engaged in research or other
scholarly activities related to the mission of the NIMH.

Program
Participants (Component of Item 3): Provide details about the pool
of proposed participants, their qualifications, recruitment strategies and
sources of applicant pool, etc. Describe the criteria that will be used to select
individuals who will participate in the program.

Diversity
Recruitment and Retention Plan (Component of Item 3): Provide a detailed diversity
recruitment and retention plan for the research education program. Renewal
applications must detail experiences in recruiting and retaining individuals
from underrepresented groups during the previous award period. To accomplish
this, include a table that for each academic year indicates the total number of
individuals who applied, the number accepted, the number who matriculated, and
the total number of individuals participating in the program. This table should
also list specifically for underrepresented racial and ethnic individuals the number who applied, the number accepted, and the number who matriculated;
and for individuals with disabilities and individuals from disadvantaged
backgrounds, the table should list the number participating in the program
each year. For those programs where individuals are not participating, e.g., a
program requesting support to develop a curriculum, the PD/PI should indicate
that this requirement is not applicable.

The NIH recognizes a unique and compelling need to
promote diversity in the biomedical, behavioral, clinical and social sciences
research workforce. The NIH expects efforts to diversify the workforce to lead
to the recruitment of the most talented researchers from all groups; to improve
the quality of the educational and training environment; to balance and broaden
the perspective in setting research priorities; to improve the ability to
recruit subjects from diverse backgrounds into clinical research protocols; and
to improve the Nation's capacity to address and eliminate health disparities.

Accordingly, the NIH continues to encourage
institutions to diversify their student and faculty populations and thus to
increase the participation of individuals currently underrepresented in the
biomedical, clinical, behavioral, and social sciences such as: individuals from
underrepresented racial and ethnic groups; individuals with disabilities; and
individuals from socially, culturally, economically, or educationally disadvantaged
backgrounds that have inhibited their ability to pursue a career in
health-related research. Institutions are encouraged to identify candidates who
will increase diversity on a national or institutional basis. The NIH is
particularly interested in encouraging the recruitment and retention of the
following classes of participants:

A. Individuals
from racial and ethnic groups that have been shown by the National Science
Foundation to be underrepresented in health-related sciences on a national
basis (see data at http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27 and the report Women, Minorities, and Persons with
Disabilities in Science and Engineering, 2007, p. 262). The following racial
and ethnic groups have been shown to be underrepresented in biomedical
research: African Americans, Hispanic Americas, Native Americans, Alaskan
Natives, Hawaiian Natives, and natives of the US Pacific Islands. In addition, it is recognized that underrepresentation can
vary from setting to setting; individuals from racial or ethnic groups that can
be convincingly demonstrated to be underrepresented by the grantee institution
should be encouraged to participate in this program

B. Individuals
with disabilities, who are defined as those with a physical or mental
impairment that substantially limits one or more major life activities.

C. Individuals
from disadvantaged backgrounds who are defined as:

Individuals
who come from a family with an annual income below established low-income
thresholds. These thresholds are based on family size; published by the U.S.
Bureau of the Census; adjusted annually for changes in the Consumer Price
Index; and adjusted by the Secretary for use in all health professions programs.
The Secretary periodically publishes these income levels at
http://aspe.hhs.gov/poverty/index.shtml. For individuals from low income
backgrounds, the institution must be able to demonstrate that such participants
have qualified for Federal disadvantaged assistance or they have received any
of the following student loans: Health Professions Student Loans (HPSL), Loans
for Disadvantaged Student Program, or they have received scholarships from the
U.S. Department of Health and Human Services under the Scholarship for
Individuals with Exceptional Financial Need.

Individuals
who come from a social, cultural, or educational environment such as that found
in certain rural or inner-city environments that have demonstrably and recently
directly inhibited the individual from obtaining the knowledge, skills, and
abilities necessary to develop and participate in a research career.

Recruitment and retention plans related to a
disadvantaged background are most applicable to high school and perhaps to
undergraduate candidates, but would be more difficult to justify for
individuals beyond that level of academic achievement. Under extraordinary circumstances the
PHS may, at its discretion, consider an individual beyond the undergraduate
level to be from a disadvantaged background. Such decisions will be made
on a case-by-case basis, based on appropriate documentation.

Peer reviewers will separately evaluate the diversity
recruitment and retention plan after the overall score has been determined.
Reviewers will examine the strategies to be used in the recruitment and
retention of individuals from underrepresented racial and ethnic groups, and
individuals with disabilities, and individuals from socially, culturally,
economically, or educationally disadvantaged backgrounds. If the diversity
recruitment and retention plan is judged to be unacceptable, funding will be
withheld until a revised plan (and report) that addresses the deficiencies is
received. Staff within the NIMH, with guidance from the appropriate national advisory
committee or council, will determine whether amended plans and reports
submitted after the initial review are acceptable.

Applications without a diversity recruitment and
retention plan will be considered incomplete and may be delayed in the review
process or not reviewed. An award cannot be made if an application lacks this
component.

Applications without a diversity recruitment and
retention plan will be considered incomplete and may be delayed in the review
process or not reviewed. An award cannot be made if an application lacks this
component.

Training
in the Responsible Conduct of Research (Component of Item 3):Every
participant supported by this Research Education grant must receive instruction
in the responsible conduct of research. All Applications must include a plan to
provide such instruction. The plan must
address five components (format; subject matter; faculty participation;
duration of instruction; and frequency of instruction) as detailed in NOT-OD-10-019.
Renewal (Type 2) applications must, in addition, describe changes in formal
instruction over the past project period and plans for the future that address
any weaknesses in the current instruction plan. All participating faculty who
served as course directors, speakers, lecturers, and/or discussion leaders
during the past project period must be named in the application.

Applications lacking a
plan for instruction in responsible conduct of research will be considered incomplete
and may be delayed in the review process or not reviewed. An award cannot be made if an
application lacks this component. The background,
rationale and more detail about instruction in the responsible conduct of
research can be found in NOT-OD-10-019.

If such instruction is not appropriate for the
proposed research education program, then the PD/PI must provide a strong
justification for its exclusion.

Evaluation
Plan (Component of Item 3): Although research education grants are not
typical research instruments, they do involve experiments in education and/or
dissemination of research knowledge that require an evaluation plan in order to
determine their effectiveness. A plan must be provided for program evaluation.
Benchmarks should be specified, and specific plans and procedures must be
described to capture, analyze and report short or long-term outcome measures
that would determine the success of the research education program in achieving
its objectives. Where appropriate, applicants are encouraged to include plans
to obtain feedback from participants to help identify weaknesses and to provide
suggestions for program improvements.

Dissemination
Plan (Component of Item 3): A specific plan must be provided to
disseminate nationally any findings resulting from or materials developed under
the auspices of the research education program, e.g., sample curricula, web
postings, presentations at scientific meetings, workshops, etc.

Select Agent
Research (Item 11): If participating
faculty proposed in the Research Education program are conducting or plan to
conduct research involving select agents in which participant are involved,
follow the instructions in SF424, Section 5.5, and include the appropriate
information.

Resource
Sharing Plan(s) (Item 15): NIH considers the
sharing of unique research resources developed through NIH-sponsored research
an important means to enhance the value and further the advancement of the
research. When resources have been developed with NIH funds and the associated
research findings published or provided to NIH, it is important that they be
made readily available for research purposes to qualified individuals within
the scientific community. If the final data/resources
are not amenable to sharing, this should be explained in the Resource Sharing
section of the application (see http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.)

(a) Data Sharing Plan:
Not applicable.

(b) Sharing Model Organisms:
Regardless of the amount requested, all applications in which the development
of model organisms is anticipated are expectedto include a
description of a specific plan for sharing and distributing unique model
organisms and related resources, or state appropriate reasons why such sharing
is restricted or not possible (see Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.)

(c) Genome-Wide Association
Studies (GWAS): Regardless of the amount requested, applicants
seeking funding for a genome-wide association study are expected to
provide a plan for submission of GWAS data to the NIH-designatedGWAS
data repository, or provide an appropriate explanation why submission to the
repository is not possible. A genome-wide association study is defined as any
study of genetic variation across the entire genome that is designed to
identify genetic associations with observable traits (e.g., blood pressure or
weight) or the presence or absence of a disease or condition. For further
information see Policy for Sharing of
Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies(NOT-OD-07-088) and http://grants.nih.gov/grants/gwas/.

(d) Research education programs: These programs are not generally expected
to generate research resources. However, applications are expected to include a
software dissemination plan if support for development, maintenance, or
enhancement of software is requested in the application. There is no prescribed
single license for software produced. However, the software dissemination plan
should address, as appropriate, the following goals:

Software source code should be
freely available to biomedical researchers and educators in the non-profit
sector, such as institutions of education, research institutions, and
government laboratories. Users should be permitted to modify the code and share
their modifications with others.

The terms of software availability
should permit the commercialization of enhanced or customized versions of the
software, or incorporation of the software or pieces of it into other software
packages.

To preserve utility to the
community, the software should be transferable such that another individual or
team can continue development in the event that the original investigators are
unwilling or unable to do so.

The
initial review group will comment on the appropriateness of the proposed
software dissemination plan. Program staff will also consider the adequacy of
the software dissemination plan as one of the criteria for award.

The
proposed sharing plan, after negotiation with the applicant when necessary,
will be made a condition of the award. Evaluation of annual non-competing
progress reports will include assessment of the dissemination practice by the
grantee. The adequacy of the resources sharing plan
and any related data sharing plans (if applicable) will be considered by
Program staff of the funding organization when making recommendations about
funding applications. The effectiveness of the resource sharing will be
evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590). See Section VI.3., “Reporting.”

Do not use the Appendix to circumvent
the page limitations. An application that does not comply with the required
page limitations may be delayed in the review process.

SF 424 Research & Related Other Project
Information

Item
9 (Facilities & Other Resources): Describe the educational
environment, including the facilities, laboratories, participating departments,
computer services, and any other resources to be used in the development and
implementation of the proposed program. List all thematically related sources
of support for research training and education following the format for Current
and Pending Support.

SF 424 Research & Related Senior/Key Person
Profile

Key Personnel must include the PD/PI (or multiple PDs/PIs)as well as any other key persons (such as those involved in developing, implementing,
directing, monitoring, evaluating, etc., who are integral to the proposed
research education program) participating in the
research education program.

Research & Related Budget

Complete for each budget period requested.

A. Senior/Key Person: complete for all senior/key persons associated with
the research education program. The PD/PI (or multiple PDs/PIs)must be included here.B. Other Personnel: complete for all other personnel (including clerical
and administrative staff) associated with the research education program.C. Equipment: self-explanatory.D. Travel: include here any travel funds requested for senior/key
persons and other personnel (i.e. those persons identified in Sections A. and
B.) associated with the research education program.E. Participant/Trainee Support Costs: include here all allowable
categories of funds requested to support participants in the research education
program. If categories in addition to those listed in this section of the
424R&R form are needed, describe in Other. State the number of
Participants/Trainees to be supported by the proposed research education
program. Refer
to Section II.2 for allowable participant support costs.F. Other Direct Costs: itemize as appropriate and allowed for the research
education program.K. Budget Justification: provide a detailed justification for each category
for which funds are requested. For Section E, itemize each category of support
costs per participant and justify. Note that the total funds requested in Sections A + B may
not exceed 25% of the total direct costs in any year of the project period.

Section V. Application Review Information

1. Criteria

Only
the review criteria described below will be considered in the review process.

2. Review and Selection Process

The mission of the NIH is to support science
in pursuit of knowledge about the biology and behavior of living systems and to
apply that knowledge to extend healthy life and reduce the burdens of illness
and disability. As part of this mission, applications submitted to the NIH for
grants or cooperative agreements to support biomedical and behavioral research
are evaluated for scientific and technical merit through the NIH peer review
system.

Review Process

Applications that are
complete will be evaluated for scientific and technical merit by an appropriate
peer review group convened by NIMH and in accordance with NIH peer review procedures
(http://grants1.nih.gov/grants/peer/),
using the review criteria stated below.

As part of the initial merit review, all applications will:

Undergo a
selection process in which only those applications deemed to have the
highest scientific merit, generally the top half of applications under
review, will be discussed and assigned an overall impact/priority score;

Receive a
written critique; and

Receive
a second level of review by the National Advisory Mental Health Council.

The goals of NIH-supported research training,
education, and career development programs are to help ensure that a diverse
pool of highly trained scientists is available in adequate numbers and in
appropriate scientific areas to address the Nation’s biomedical, behavioral,
and clinical research needs. The goals of NIH-supported science education
projects at science centers and museums are to provide public education and
outreach on NIH-supported research at these institutions.

Research education program grant applications
submitted in response to this funding opportunity announcement should be
characterized by innovation, scholarship and responsiveness to the priorities
and/or changing needs of the NIMH in meeting its objectives. Applicants are strongly
encouraged to contact NIMH program staff for current information about targeted
priorities and policies before preparing an application (see Section VII).

Overall Impact

Reviewers
will provide an overall impact/priority score to reflect their assessment of
the likelihood for the research education program to exert a sustained,
powerful influence on the activities involved, in consideration of the
following five scored review criteria, and additional review criteria (as
applicable for the proposed program).

Scored Review Criteria

Reviewers will consider each of the five review criteria
below in the determination of scientific merit, and give a separate score for
each. An application does not need to be strong in all categories to be judged
likely to have major scientific impact. For example, a project that by its
nature is not innovative may be essential to advance a field.

Significance: Does the proposed research
education program address an important problem or critical question in research
education or other critical issues as outlined in this funding opportunity
announcement (FOA)? How will implementation of the proposed program advance the
objectives of this FOA? If the aims of the education program are achieved, will
they achieve the intended purpose of this FOA?

Investigator(s): Are the PD/PIs,
collaborators, and other researchers appropriately trained and well suited to
the proposed research education program? Is the PD/PI an established investigator
in the scientific area in which the application is targeted and capable of
providing both administrative and scientific leadership to the development and
implementation of the proposed research education program? If Early Stage
Investigator or New Investigator, does the PD/PI have appropriate experience to
lead the program? If the project is collaborative or multi-PD/PI, do the
investigators have complementary and integrated expertise; are their leadership
approach, governance and organizational structure appropriate for the project?
Is there evidence that an appropriate level of effort will be devoted by the
program leadership to ensure the program's objectives?

Innovation: Is the proposed research
education program characterized by innovation and scholarship? Does the
proposed program challenge and seek to shift current research education
paradigms or clinical practice; address an innovative hypothesis or critical
barrier to progress in the field? Are the proposed concepts, approaches,
methodologies, tools, or technologies novel for this area? Does this proposed
program duplicate, or overlap with, existing research education, training
and/or career development activities currently supported at the applicant
institution or available elsewhere? Adaptations of existing research education
programs may be considered innovative under special circumstances, e.g., the
addition of unique components and/or a proposal to determine portability of an
existing program. If short courses and/or workshops are proposed, do they
provide state-of-the-art educational opportunities?

Approach: Are the overall strategy,
methodology, and analyses well reasoned and appropriate to accomplish the
specific aims of the proposed research education program? Are potential
problems, alternative strategies, and benchmarks for success presented? If the
program is in the early stages of development, will the strategy establish
feasibility and will particularly risky aspects be managed? If called for in
the FOA, is the proposed plan for evaluation and/or dissemination of the
education program sound and likely to provide data on the effectiveness of the
education program? Is there evidence that the program is based on sound
research concepts and educational principles? Is the approach feasible and
appropriate to achieve the stated research education goals? If the proposed program will recruit participants,
are the recruitment, retention, and follow-up (if appropriate) activities
adequate to ensure a sufficiently large, highly qualified and diverse
participant pool? lf the research education program targets research-oriented
physician-scientists during medical school and/or residency, is the program
structured to facilitate the development of appropriate scientific expertise
and to encourage sustained interest in a career as a physician-scientist? If
research mentoring networks are proposed, are there specific plans to
facilitate efficient and effective communication among network members, both
mentors and participants, and to achieve a balance between network security and
appropriate access to and dissemination of information beyond the network?

Environment:Will the scientific/educational environment in which
the proposed research education program will be conducted contribute to the
probability of success? Are the institutional commitment and support, equipment
and other physical resources available to the investigators adequate for the
program proposed? Will the program benefit from unique features of the
scientific environment, subject populations, or collaborative arrangements? Is
there evidence of appropriate collaboration among participating programs,
departments, and institutions? If multiple sites are participating, is this
adequately justified in terms of the research education experiences provided?
Are adequate plans provided for coordination and communication between multiple
sites (if appropriate)? Are there adequate
plans to ensure coordination among other training or career development
programs at the applicant and cooperating institutions, as appropriate, while
ensuring that the proposed program is distinct from other extant programs (if
applicable)?

Additional
Review Criteria

As
applicable for the program proposed, reviewers will consider the following additional items in the determination
of scientific merit, but will not give separate scores for these items.

Protections
for Human Subjects: For
research that involves human subjects but does not involve one of the six
categories of research that are exempt under 45 CFR Part 46, the committee will
evaluate the justification for involvement of human subjects and the proposed
protections from research risk relating to their participation according to the
following five review criteria: 1) risk to subjects, 2) adequacy of protection
against risks, 3) potential benefits to the subjects and others, 4) importance
of the knowledge to be gained, and 5) data and safety monitoring for clinical
trials.

For
research that involves human subjects and meets the criteria for one or more of
the six categories of research that are exempt under 45 CFR Part 46, the
committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials.

Inclusion
of Women, Minorities and Children: When the
proposed project involves clinical research, the committee will evaluate the
proposed plans for inclusion of minorities and members of both genders, as well
as the inclusion of children.

Vertebrate
Animals: The committee will evaluate the involvement of live
vertebrate animals as part of the scientific assessment according to the
following five points: 1) proposed use of the animals, and species, strains,
ages, sex, and numbers to be used; 2) justifications for the use of animals and
for the appropriateness of the species and numbers proposed; 3) adequacy of
veterinary care; 4) procedures for limiting discomfort, distress, pain and
injury to that which is unavoidable in the conduct of scientifically sound
research including the use of analgesic, anesthetic, and tranquilizing drugs
and/or comfortable restraining devices; and 5) methods of euthanasia and reason
for selection if not consistent with the AVMA Guidelines on Euthanasia. For
additional information, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.

Biohazards: Reviewers will assess whether materials or procedures proposed are
potentially hazardous to research personnel and/or the environment, and if
needed, determine whether adequate protection is proposed.

Resubmission Applications:When reviewing a Resubmission application (formerly called an amended
application), the committee will evaluate the application as now presented,
taking into consideration the responses to comments from the previous
scientific review group and changes made to the program.

Renewal
Applications: When reviewing a Renewal
application (formerly called a competing continuation application), the
committee will consider the progress made in the last funding period. In
addition, the committee will consider the following:

Has the research education program successfully achieved its
stated objectives during the prior project period?

Has the research education program
successfully recruited a diverse pool of participants (if applicable)? Has
the PD/PI effectively shaped the recruitment plan in response to
recruitment outcomes?

Has the program been innovative in the past and does it
continue to demonstrate innovation?

Has
the program documented a strong need for continued support?

Additional
Review Considerations

As
applicable for the project proposed, reviewers will address each of the
following items, but will not give scores for these items and should not
consider them in providing an overall impact/priority score.

Diversity
Recruitment and Retention Plan: Reviewers will examine the strategies to be used in the
recruitment and retention of individuals from underrepresented racial and
ethnic groups, individuals with disabilities, and individuals from socially,
culturally, economically, or educationally disadvantaged backgrounds. Plans and past record (if a renewal
application) will be rated as ACCEPTABLE or UNACCEPTABLE.

Training
in the Responsible Conduct of Research: Reviewers will evaluate plans for instruction in responsible conduct of
research as well as the past record of instruction in responsible conduct of
research, where applicable. Reviewers will specifically address the five
Instructional Components (Format, Subject Matter, Faculty Participation,
Duration and Frequency) taking into account the characteristics of the proposed
Research Education program. Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE. Applications with unacceptable plans will not be funded
until the applicant provides an acceptable, revised plan.

Applications from Foreign Organizations: When applicable, reviewers will assess whether the project presents
special opportunities for furthering research programs through the use of
unusual talent, resources, populations, or environmental conditions that exist
in other countries and either are not readily available in the United States or
augment existing U.S. resources.

Select Agents Research: When applicable, reviewers will
assess the information provided in this section of the application, including
1) the Select Agent(s) to be used in the proposed research, 2) the registration
status of all entities where Select Agent(s) will be used, 3) the procedures
that will be used to monitor possession use and transfer of Select Agent(s),
and 4) plans for appropriate biosafety, biocontainment, and security of the
Select Agent(s).

Budget and Period of Support: Reviewers will consider whether the budget and the requested
period of support are fully justified and reasonable in relation to the
proposed research education program and the number of proposed participants.

Selection Process

Applications submitted in response to this funding
opportunity will compete for available funds with all other recommended
applications. The following will be considered in making funding decisions:

Scientific merit
of the proposed project as determined by scientific peer review.

Availability of
funds.

Relevance of
the proposed Education Program to program priorities.

3. Anticipated Announcement and Award Dates

Not Applicable

Section
VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the PD/PI will be able
to access his or her Summary Statement (written critique) via the NIH eRA Commons.

A formal notification in the form of a Notice of Award
(NoA) will be provided to the applicant organization. The NoA signed by the
grants management officer is the authorizing document. Once all administrative
and programmatic issues have been resolved, the NoA will be generated via email
notification from the Institute to the grantee business official.

Selection of an application for award is not an
authorization to begin performance. Any allowable costs incurred 90 days before
the beginning (or start) date of the Notice of Award (NoA) are at the recipient's
risk. These costs may be reimbursed only to the extent considered allowable
pre-award costs. See Section IV.5., “Funding Restrictions.”

Termination of Award: When a grantee
institution plans to terminate an award, program and grants management staff at
the NIH funding component must be notified in writing as soon as possible.

Change of Institution: The research
education program may not be transferred from one institution to another.

Change of Program: Awards are made
for a specific program under the guidance and leadership of a particular PD/PI.
A change in any of these parameters requires prior approval by the responsible
program officer in the NIH funding component. A rationale must be provided for
any proposed changes in the aims of the original, peer-reviewed program. If the
new program does not satisfy this requirement, the award will be terminated.

Change of PD/PI: If change of the
PD/PI is necessary, support of the award is not automatic but may be continued
with prior written approval by the NIH funding component, provided that the
following conditions are met. The current PD/PI or the grantee institution must
submit a written request for the change, signed by the appropriate
institutional business official, to the responsible program officer of the NIH
funding component that describes the reasons for the change. The Biographical
Sketch of the proposed PD/PI, including a complete listing of active research
grant support, must be provided. The information in the request must establish
that the Specific Aims of the original peer-reviewed research education program
will remain unchanged under the direction of the new PD/PI and that the new PD/PI
has the appropriate research and administrative expertise to lead the program.
This request must be submitted sufficiently in advance of the requested
effective date to allow the necessary time for review.

3. Reporting

Awards made in response to this FOA are not subject to the streamlined non-competing application process (SNAP).

The Progress Report should provide
information on the development and implementation of the proposed research
education program, modifications to the research education program as
originally proposed, updates on the evaluation of the research education
program and dissemination activities (if applicable), and a list of any
publications and/or other materials arising from the research education
program. To
facilitate and standardize reporting, programs that involve participants should
report on education in the responsible conduct of research and complete a Training Diversity
Report,
in accordance with the PHS 2590 additional instructions for preparing a
Progress Report for an institutional training grant.

Evaluation: In carrying out
its stewardship of human resource-related programs, the NIH may request
information essential to an assessment of the effectiveness of this program.
Accordingly, award participants are hereby notified that they may be contacted
after completion of this award for periodic updates on various aspects of
program development, implementation, dissemination, and other information
helpful in evaluating the impact of this program.

Publication and Sharing of Research
Education Results: Investigators are
encouraged to submit reports of their findings for publication to the journals
of their choice. For each publication that results from this award, NIH support
should be acknowledged by a footnote in language similar to the following:
“This project was supported by NIH grant number ________. Its contents are
solely the responsibility of the authors and do not necessarily represent the
official views of the NIH.”

Failure by the grantee institution to submit the required
forms in a timely, complete, and accurate manner may result in an expenditure
disallowance or a delay in any continuation funding for the award. Forms may be
found on the NIH Website at http://grants.nih.gov/grants/forms.htm

Final Reports: A final Progress
Report and Financial Status Report are required when an award is terminated.
Evaluation results should be included as part of the Final Progress Report.

Statement
of Appointment: The institution
must submit a completed Statement of Appointment (PHS Form 2271) for each
participant appointed continuously for eight weeks or more. Appointment forms
need not be submitted for participants in mentoring networks. More information on xTrain
is available at http://era.nih.gov/training_career/index.cfm. An appointment or reappointment
may begin any time during the budget period, but not before the budget period
start date of the grant year.

Termination
Notice: Within
30 days of the end of the total support period for each participant, the
institution must submit a Termination Notice (PHS Form 416-7) to the NIH for each participant
appointed for eight weeks or more. If registered in the NIH eRA Commons,
grantees are encouraged to submit the PHS 416-7 data electronically using the xTrain
system. More information on xTrain is available at https://commons.era.gov/commons/.

Section VII. Agency Contacts

We encourage your inquiries concerning this funding
opportunity and welcome the opportunity to answer questions from potential
applicants. Inquiries may fall into three areas: scientific/research, peer
review, and financial or grants management issues:

Human
Subjects Protection:Federal regulations (45 CFR 46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and others,
and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data
and Safety Monitoring Plan:Data and safety monitoring is required for all types
of clinical trials, including physiologic toxicity and dose-finding studies
(Phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative
trials (Phase III). Monitoring should be commensurate with risk. The
establishment of data and safety monitoring boards (DSMBs) is required for
multi-site clinical trials involving interventions that entail potential risks
to the participants (“NIH Policy for Data and Safety Monitoring,” NIH Guide
for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing
Research Data:Investigators submitting an NIH application seeking
$500,000 or more in direct costs in any single year are expected to include a
plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).Investigators should seek
guidance from their institutions, on issues related to institutional policies
and local institutional review board (IRB) rules, as well as local, State and
Federal laws and regulations, including the Privacy Rule.

Policy for Genome-Wide
Association Studies (GWAS):NIH is interested in
advancing genome-wide association studies (GWAS) to identify common genetic
factors that influence health and disease through a centralized GWAS data
repository. For the purposes of this policy, a genome-wide association study is
defined as any study of genetic variation across the entire human genome that
is designed to identify genetic associations with observable traits (such as
blood pressure or weight), or the presence or absence of a disease or
condition. All applications, regardless of the amount requested, proposing a
genome-wide association study are expected to provide a plan for submission of
GWAS data to the NIH-designated GWAS data repository, or provide an appropriate
explanation why submission to the repository is not possible. Data repository
management (submission and access) is governed by the Policy for Sharing of
Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH
Guide NOT-OD-07-088. For additional information,
see http://grants.nih.gov/grants/gwas/.

Sharing of Model Organisms:NIH is committed to support efforts that encourage
sharing of important research resources including the sharing of model
organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH
recognizes the rights of grantees and contractors to elect and retain title to
subject inventions developed with Federal funding pursuant to the Bayh-Dole Act
(see the NIH Grants Policy Statement. Beginning October 1, 2004,
all investigators submitting an NIH application or contract proposal are
expected to include in the application/proposal a description of a specific
plan for sharing and distributing unique model organism research resources
generated using NIH funding or state why such sharing is restricted or not
possible. This will permit other researchers to benefit from the resources
developed with public funding. The inclusion of a model organism sharing plan
is not subject to a cost threshold in any year and is expected to be included
in all applications where the development of model organisms is anticipated.

Access to Research Data through the Freedom of
Information Act:The Office of Management and Budget (OMB) Circular
A-110 has been revised to provide access to research data through the Freedom
of Information Act (FOIA) under some circumstances. Data that are: (1) first
produced in a project that is supported in whole or in part with Federal funds;
and (2) cited publicly and officially by a Federal agency in support of an
action that has the force and effect of law (i.e., a regulation) may be
accessed through FOIA. It is important for applicants to understand the basic
scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to
place data collected under this funding opportunity in a public archive, which
can provide protections for the data and manage the distribution for an
indefinite period of time. If so, the application should include a description
of the archiving plan in the study design and include information about this in
the budget justification section of the application. In addition, applicants
should think about how to structure informed consent statements and other human
subjects procedures given the potential for wider use of data collected under
this award.

Inclusion of Women And Minorities in Clinical
Research:It is the policy of the NIH that women and members of
minority groups and their sub-populations must be included in all NIH-supported
clinical research projects unless a clear and compelling justification is
provided indicating that inclusion is inappropriate with respect to the health
of the subjects or the purpose of the research. This policy results from the
NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All
investigators proposing clinical research should read the "NIH Guidelines
for Inclusion of Women and Minorities as Subjects in Clinical Research” (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the
updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy
incorporates: the use of an NIH definition of clinical research; updated racial
and ethnic categories in compliance with the new OMB standards; clarification
of language governing NIH-defined Phase III clinical trials consistent with the
SF424 (R&R) application; and updated roles and responsibilities of NIH
staff and the extramural community. The policy continues to require for all
NIH-defined Phase III clinical trials that: a) all applications or proposals
and/or protocols must provide a description of plans to conduct analyses, as
appropriate, to address differences by sex/gender and/or racial/ethnic groups,
including subgroups if applicable; and b) investigators must report annual
accrual and progress in conducting analyses, as appropriate, by sex/gender
and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical
Research:The NIH maintains a policy that children (i.e.,
individuals under the age of 21) must be included in all clinical research,
conducted or supported by the NIH, unless there are scientific and ethical
reasons not to include them.

Required Education on the Protection of Human Subject
Participants:NIH policy requires education on the protection of
human subject participants for all investigators submitting NIH applications
for research involving human subjects and individuals designated as key
personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy, investigators
funded by the NIH must submit or have submitted for them to the National
Library of Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final,
peer-reviewed manuscripts upon acceptance for publication, to be made publicly
available no later than 12 months after the official date of publication. The
NIH Public Access Policy is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html).For more
information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable
Health Information:The Department of Health and Human Services (HHS)
issued final modification to the "Standards for Privacy of Individually
Identifiable Health Information", the "Privacy Rule", on August
14, 2002. The Privacy Rule is a federal regulation under the Health Insurance
Portability and Accountability Act (HIPAA) of 1996 that governs the protection
of individually identifiable health information, and is administered and
enforced by the HHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of
the Privacy Rule reside with the researcher and his/her institution. The OCR
website (http://www.hhs.gov/ocr/) provides information on the
Privacy Rule, including a complete Regulation Text and a set of decision tools
on "Am I a covered entity?" Information on the impact of the HIPAA
Privacy Rule on NIH processes involving the review, funding, and progress
monitoring of grants, cooperative agreements, and research contracts can be
found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:All
applications and proposals for NIH funding must be self-contained within
specified page limitations. For publications listed in the appendix and/or
Progress report, Internet addresses (URLs) or PubMed Central (PMC) submission
identification numbers must be used for publicly accessible on-line journal
articles. Publicly accessible on-line journal articles or PMC
articles/manuscripts accepted for publication that are directly relevant to the
project may be included only as URLs or PMC submission
identification numbers accompanying the full reference in either the
Bibliography & References Cited section, the Progress Report Publication
List section, or the Biographical Sketch section of the NIH grant application.
A URL or PMC submission identification number citation may be repeated in each
of these sections as appropriate. There is no limit to the number of URLs or
PMC submission identification numbers that can be cited.

Healthy People 2010:The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of
"Healthy People 2010," a PHS-led national activity for setting
priority areas. This FOA is related to one or more of the priority areas.
Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:This program is
described in the Catalog of Federal
Domestic Assistance athttp://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order
12372. Awards are made under the authorization of Sections 301 and 405 of the
Public Health Service Act as amended (42 USC 241 and 284) and under Federal
Regulations 42 CFR Part 52 and 45 CFR Parts 74 and
92. All awards are subject to the terms and conditions, cost principles, and
other considerations described in the NIH
Grants Policy Statement.

The PHS strongly encourages all grant recipients to
provide a smoke-free workplace and discourage the use of all tobacco products.
In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits
smoking in certain facilities (or in some cases, any portion of a facility) in
which regular or routine education, library, day care, health care, or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.

Loan Repayment Programs:NIH encourages applications for educational loan
repayment from qualified health professionals who have made a commitment to
pursue a research career involving clinical, pediatric, contraception,
infertility, and health disparities related areas. The LRP is an important
component of NIH's efforts to recruit and retain the next generation of
researchers by providing the means for developing a research career unfettered
by the burden of student loan debt. Note that an NIH grant is not required for
eligibility and concurrent career award and LRP applications are encouraged.
The periods of career award and LRP award may overlap providing the LRP
recipient with the required commitment of time and effort, as LRP awardees must
commit at least 50% of their time (at least 20 hours per week based on a 40
hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov/.